What this study is
The purpose of this study is to collect real-world data to describe the effectiveness and tolerability of first line (1L) zanidatamab-containing therapies and describe the subsequent lines of treatment in participants with unresectable, locally advanced, recurrent or metastatic HER2-positive gastroesophageal adenocarcinoma (GEA) (HER2+ la/m GEA).
What's being tested
- Zanidatamab
Intervention · DRUG
Administered via intravenous (IV) infusion
Study details
- Official title
- Real-World Utilization, Treatment Patterns, Tolerability, and Effectiveness of Zanidatamab in Patients With Unresectable Locally Advanced, Recurrent or Metastatic HER2-Positive Gastroesophageal Adenocarcinoma in the United States
- Sponsor
- Jazz Pharmaceuticals
- Conditions
- Esophageal Cancer · GastroEsophageal Cancer · Gastroesophageal-junction Cancer · HER2-positive Gastric Cancer · Stomach Cancer
- Enrolling
- 300 people
- Starts
- 2026-11-30
- Est. completion
- 2031-10-01
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Histologically confirmed HER2-positive (defined as IHC3+ or IHC2+ with ISH positivity) locally advanced or metastatic GEA
- Documented plan to initiate a zanidatamab-containing therapy as 1L treatment
- Sufficient cognitive capacity and language proficiency to complete patient-reported outcomes (PRO) questions
- 18 years of age or older on the date of initiating 1L zanidatamab-containing therapy
You can't join if
- Receiving a zanidatamab-containing therapy as part of a clinical trial or expanded access program
- Received zanidatamab prior to the approval date by the FDA for HER2+ la/m GEA
- Received the first infusion of zanidatamab prior to providing study consent
- For patients initiating chemotherapy backbone first, more than 2 months have elapsed before the first dose of zanidatamab
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (2)
2 openUCI Health - Chao Family Comprehensive Cancer Center
Orange, California, United States
University of Texas - MD Anderson Cancer Center Gastrointestinal Cancer Center
Houston, Texas, United States
Study team
Sponsor
Jazz Pharmaceuticals
Study ID JZP598-401
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.